Using a Smart Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorChildren's Hospital Los Angeles

About this trial

Correct use of daily medications containing inhaled corticosteroids is key for asthma control, yet children with intellectual and developmental disabilities (IDD) face additional barriers to proper inhaler use. Smart inhalers, a novel technology that provides guidance and immediate feedback on inhaler use techniques, have been shown to enhance correct medication administration in the typically developing pediatric population, but their effectiveness has not been evaluated on the pediatric IDD population. This study aims to investigate whether daily application of smart inhalers (1) is feasible and acceptable in the IDD population, (2) improves the rate of correct medication administration, and (3) results in improvement in lung function. This effort aims to promote better asthma management in the IDD population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adolescents ages 10-17 years

Diagnosis of mild-to-moderate intellectual disability: ICD-10: F70-F71 and/or diagnosis of developmental disability, including autism: ICD-10: F80-89

Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma: ICD-10: J45.40-J45.909

Parent/legal guardian is willing to answer questions about their child.

Disqualifiers

Health status or any clinical conditions: Limited life expectancy, co-existing disease or other characteristics that precludes appropriate diagnosis, treatment, or follow-up in the trial.

Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Use of smart inhaler to enhance asthma inhaler proficiency

    Behavioral

    The application of the smart inhaler technology to enhance asthma inhaler proficiency

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of smart inhaler device

Feasibility will be determined by data completeness: Ratio of days on which there are valid smart inhaler data out of the total number of days

Time frame
Weeks 1-8
2

Acceptability of smart inhaler

Acceptability will be measured by response rate on user satisfaction survey.

Time frame
Weeks 4 and 8
3

Usability of smart inhaler

Usability will be measured by ease of use smart inhaler survey.

Time frame
Weeks 4 and 8

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.